A double-blind randomized placebo control trial utilizing Calcarea Phos 6x in mitigating musculoskeletal manifestations in individuals with vitamin D3 deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- To assess the effect of Calcarea Phos 6x in mitigating manifestations related to the musculoskeletal system in individuals with Vitamin D3 deficiency.
研究概览
简要总结
This is a randomised, double-blind, placebo-controlled clinical study. The primary objective of the study is to assess the efficacy of Calcarea phos 6x in mitigating manifestations pertaining to the musculoskeletal system in individuals with vitamin D3 deficiency. Minimum 52 patients at Bharati Vidhyapeeth (deemed to be a university) Homoeopathic Medical College and Hospital will be enrolled in the study. Patient scoring VDIP score 7 or above will be selected, with 52 participants split into two groups: 26 receiving a placebo and 26 receiving Calcarea phos 6x. Randomization will occur through a coin toss. Head will be control group and tail will be treatment group. Follow-up occurs every 15 days for 3 months, measuring serum vitamin D3 levels before and after treatment. The final assessment will determine changes in vitamin D3 levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient attending OPD who falls short of VDIP score will be included for the study.
- •2.Age group:18 to 45 years.
- •3.Patients of both sexes.
- •4.Patients irrespective of their community or socio-economic status.
- •5.Patient who has given the consent flr the study.
排除标准
- •Patient is already under vitamin D supplementation.
- •2.Pregnant and lactating woman.
- •3.Patient having chronic illness or are critically ill.
- •Patient having defined life-threatening pathology.
结局指标
主要结局
To assess the effect of Calcarea Phos 6x in mitigating manifestations related to the musculoskeletal system in individuals with Vitamin D3 deficiency.
时间窗: 3 months with follow-up in each 15 days
次要结局
- To study the role of psora in deficiency diseases.(3 months with follow-up in each 15 days.)
- To assess symptomatic improvement in vitamin D3 deficiency before and after the treatment.(3 months with follow-up in each 15 days along with serum vitamin D3 levels before and after treatment.)
研究者
Dr Aswani P U
Bharati Vidyapeeth deemed to be university Homoeopathic medical college and hospital